The impact of connecting medical devices

4. Regulations: certifying healthcare facilities

E-health workers all agree that interoperability is paramount. In Europe, like in the United States, a series of regulatory provisions is already used to oversee collecting healthcare data: regulation, labelling and certification depending on the respective devices. Benefiting from a validated and functional interoperable system enables healthcare facilities to gain easier access to existing certification defined by the National Authority for Health (HAS) in France.

Their main purpose is:

To manage the quality and risks in healthcare teams’ real life daily
situations

A truly quality ongoing approach thanks to the definition of priorities
corresponding to real issues in establishments

To respect rules about identity vigilance

CERTIFICATION is an external evaluation procedure done independently from the
facility and its governing body. Healthcare professionals appointed by the HAS carry out certification visits using a manual. This repository enables the healthcare facility’s
overall state of operations to be assessed. Implemented by the HAS, the certification procedure takes place every 4 years. Its aim is to give an independent assessment of the
quality of the facility’s services

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